510(k) · Cleared
ClearedMetaNeb 4 System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Hill-Rom Services Pte, Ltd. · NHJ Device, Positive Pressure Breathing, Intermittent
Cleared on Mar 17, 2016 as substantially equivalent to K124032 (Hill-Rom Services Pte, Ltd., 2013) and 2 other predicates after a 268-day review. Its family tree reaches back 4 generations to 1995. 2 of the 12 devices in its family, counting itself, have a Class I recall. 5 later devices descend from it.
- Decided
- Mar 17, 2016
- Review
- 268 days
- Class
- Class II
- Product code
- NHJ
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 4 generations to K944900 (1995). 6 ancestors in all, the oldest K895485 (1989). 5 later devices descend from it, 1 citing it directly. 2 of the 12 devices in this family, counting this one, have a Class I recall.
- Root · 4 generations backK944900 TherapepDhd Diemolding Healthcare Div. · 1995
- 3 generations backK991300 Boeing, Positive Airway Pressure (Pap) Therapy DeviceDhd Healthcare Corp. · 1999
- 2 generations backK051964 PowernebComedica, Inc. · 2005
- 1 generation backK124032 MetanebHill-Rom Services Pte, Ltd. · 2013
- This deviceK151689 MetaNeb 4 SystemHill-Rom Services Pte, Ltd. · 2016
- Descendant · cites it directly · 4 of its ownK192143 Maximus SystemHill-Rom Services Pte, Ltd. · 2020 · Recalled (Class I)
- Descendant · 2 generations on · 3 of its ownK200988 Maximus SystemHill-Rom Services Pte, Ltd. · 2020 · Recalled (Class I)
- Descendant · 3 generations on · 1 of its ownK231728 BiWaze Clear SystemAbmrc, LLC · 2024
- Descendant · 4 generations on · 0 of its ownK260604 BiWaze Clear SystemAbmrc, LLC · 2026
- Descendant · 3 generations on · 0 of its ownK213564 BiWaze Clear SystemAbmrc, LLC · 2022
Class I recalls in this family
Most influential descendants
Showing 5 of 5 · See all- K192143Maximus SystemHill-Rom Services Pte, Ltd. · 2020 · cites it directly4descendants
- K200988Maximus SystemHill-Rom Services Pte, Ltd. · 2020 · 2 generations on3descendants
- K231728BiWaze Clear SystemAbmrc, LLC · 2024 · 3 generations on1descendant
- K260604BiWaze Clear SystemAbmrc, LLC · 2026 · 4 generations on0descendants
- K213564BiWaze Clear SystemAbmrc, LLC · 2022 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K944900 | Therapep | Dhd Diemolding Healthcare Div. | 1995 | — |
| −3 | K991300 | Boeing, Positive Airway Pressure (Pap) Therapy Device | Dhd Healthcare Corp. | 1999 | — |
| −2 | K051964 | Powerneb | Comedica, Inc. | 2005 | — |
| −1 | K124032 | Metaneb | Hill-Rom Services Pte, Ltd. | 2013 | — |
| 0 (this device) | K151689 | MetaNeb 4 System | Hill-Rom Services Pte, Ltd. | 2016 | — |
| +1 | K192143 | Maximus System | Hill-Rom Services Pte, Ltd. | 2020 | Class I |
| +2 | K200988 | Maximus System | Hill-Rom Services Pte, Ltd. | 2020 | Class I |
| +3 | K231728 | BiWaze Clear System | Abmrc, LLC | 2024 | — |
| +4 | K260604 | BiWaze Clear System | Abmrc, LLC | 2026 | — |
| +3 | K213564 | BiWaze Clear System | Abmrc, LLC | 2022 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1989 | 1 | 0 |
| 1996 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2020 | 2 | 2 |
| 2022 | 1 | 0 |
| 2024 | 1 | 0 |
| 2026 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
2 devices in this family have a Class I recall. A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new NHJ device
- #1 K260604 BiWaze Clear Systemscore 14.0 · 8 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (3)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K124032 | MetanebSummary page 4…e: NHJ – non-continuous ventilator (IPPB) 21 CFR 868.5905 Class II Predicate Devices: K124032 – Hill-Rom – MetaNeb® K051964 – CoMedica – PowerNeb® K895485 – Pe… | 2013 |
| * | K051964 | PowernebSummary page 4…21 CFR 868.5905 Class II Predicate Devices: K124032 – Hill-Rom – MetaNeb® K051964 – CoMedica – PowerNeb® K895485 – Percussionaire Corp (Bird) – IPV Device Description: The MetaNe… | 2005 |
| * | K895485 | Bird (Ipv) Noncontinuous VentilatorsSummary page 4…Class II Predicate Devices: K124032 – Hill-Rom – MetaNeb® K051964 – CoMedica – PowerNeb® K895485 – Percussionaire Corp (Bird) – IPV Device Description: The MetaNeb® 4 System is a therapeutic device that uses a systematic appr… | 1989 |
What descends from it? (5)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K192143 | Maximus System Class I | 2020 | 4 |
Has anything in its family been recalled? (2 Class I)
No FDA recall names this device.
Relatives with a Class I recall
Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.
What does this lineage say?
- The line of descent spans 21 years and passes through 4 companies; a new generation was cleared every 6.4 years on median.
- None of the 6 ancestors has a recall.
- Of its descendants, K192143 (Hill-Rom Services Pte, Ltd., 2020) has gone furthest, with 4 descendants of its own.
- 1 other device also cites its predicate K124032.
How does its category compare?
All NHJ devicesNHJ Device, Positive Pressure Breathing, Intermittent: FDA decisions, review times, recalls and adverse event reports over 20 years. 2016, this device’s year, is highlighted.
FDA decisions per year · NHJ
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · NHJ
190in 2020
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · NHJ
11so far in 2026, the most since 2007
Class I (5 since 2007) Class II/III not classified
Adverse event reports per year · NHJ
35in 2025
MAUDE reports naming product code NHJ, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 16 |
| 2008 | 1 | — | 0 | 7 |
| 2009 | 0 | — | 0 | 1 |
| 2010 | 0 | — | 0 | 2 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 2 | — | 0 | 2 |
| 2013 | 2 | — | 0 | 2 |
| 2014 | 3 | 207 | 0 | 1 |
| 2015 | 0 | — | 0 | 2 |
| 2016 | 1 | — | 0 | 2 |
| 2017 | 0 | — | 0 | 6 |
| 2018 | 0 | — | 0 | 2 |
| 2019 | 0 | — | 0 | 1 |
| 2020 | 3 | 190 | 0 | 3 |
| 2021 | 0 | — | 0 | 5 |
| 2022 | 1 | — | 0 | 6 |
| 2023 | 0 | — | 0 | 17 |
| 2024 | 1 | — | 1 (1) | 40 |
| 2025 | 1 | — | 0 | 35 |
| 2026 | 2 | — | 11 (4) | — |
What is it indicated for?
The MetaNeb® 4 System is indicated for mobilization of secretions, lung expansion therapy, the
treatment and prevention of pulmonary atelectasis, and also has the ability to provide supplemental
oxygen when used with compressed oxygen.
Patient Population – 5 years old and above whom can follow verbal instructions.
Environment of Use – Hospitals, sub-acute and nursing facilities, physician offices, clinics, and home
settings
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K151689 · printed Nov 6, 2026
Cite this page
510(k) Report. “K151689: MetaNeb 4 System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K151689
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026